{"abstract":"The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments on evaluating the clinical pharmacology of peptides. For the purpose of this request, FDA is specifically interested in comments regarding the characterization of the effects of hepatic impairment, drug-drug interactions, and immunogenicity on the pharmacokinetics of peptides, as well as the effects of peptides on cardiac electrophysiology. However, there may be other clinical pharmacology considerations concerning the development of peptides. Public comments will help FDA develop recommendations for the design and conduct of studies important to the safe and effective use of peptides and facilitate the regulatory assessment of such studies.","action":"Notice; establishment of a public docket; request for information and comments.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2021/05/14/2021-10179.html","cfr_references":[],"citation":"86 FR 26525","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment at any time, to ensure that the Agency considers your comment in our development of recommendations, submit either electronic or written information and comments by July 13, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0347"],"dockets":[],"document_number":"2021-10179","effective_on":null,"end_page":26526,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/05/14/2021-10179.xml","html_url":"https://www.federalregister.gov/documents/2021/05/14/2021-10179/evaluating-the-clinical-pharmacology-of-peptides-establishment-of-a-public-docket-request-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-10179?publication_date=2021-05-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-05-14/2021-10179/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":4870,"last_updated":"2026-10-22 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-05-14/pdf/2021-10179.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-10179.pdf?1620909927","publication_date":"2021-05-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/05/14/2021-10179.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":9,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2021-N-0347","supporting_documents_count":0,"docket_id":"FDA-2021-N-0347","document_id":"FDA-2021-N-0347-0001","regulation_id_number":null,"title":"Evaluating the Clinical Pharmacology of Peptides; Establishment of a Public Docket; Request for Information and Comments","checked_regulationsdotgov_at":"2021-09-25T03:30:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":26525,"subtype":null,"title":"Evaluating the Clinical Pharmacology of Peptides; Establishment of a Public Docket; Request for Information and Comments","toc_doc":"Evaluating the Clinical Pharmacology of Peptides; Establishment of a Public Docket","toc_subject":"Request for Information:\n","topics":[],"type":"Notice","volume":86}